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Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05447923
Recruitment Status : Recruiting
First Posted : July 7, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial/ethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.

Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Other: Educational Intervention Other: Fecal Immunochemical Test Behavioral: Patient Navigation Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program for this community in Phoenix.

OUTLINE:

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

After completion of screening, participants with a positive FIT test are followed up at 2 and 4 weeks after initial outreach to assure participants have received adequate follow up.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area: Addressing Disparities in Cancer Prevention
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Screening (FIT, education, questionnaire, patient navigation)
Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.
 Other: Educational Intervention
Undergo education for colorectal cancer screening
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Fecal Immunochemical Test
Undergo FIT testing
Other Names:
  • FIT
  • iFOBT
  • immunoassay fecal occult blood test
  • immunochemical fecal occult blood test
  • Immunochemical FOBT
  • immunologic fecal occult blood test

Behavioral: Patient Navigation
Undergo patient navigation for positive FIT results
Other Name: Patient Navigator Program

Other: Questionnaire Administration
Complete questionnaire about colorectal cancer screening and healthcare


Outcome Measures
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Primary Outcome Measures :
  1. Colorectal cancer disparities seen in people of color and minority populations [ Time Frame: Up to study completion, up to 30 days ]
    Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 45 years of age or older
  • No prior history of colorectal cancer or colon polyps
  • No first-degree family history of colorectal cancer who were diagnosed under age 60
  • No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding)
  • Have not undergone a colonoscopy in the last 5 years
  • Have not had a fecal immunochemical test (FIT) test within the last year
  • Participants that attend 4 predominantly African American churches within the Phoenix Community and extend the study opportunity as feasible to other underserved communities in the Phoenix Metro area
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05447923


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trial Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Juliana M. Kling, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Juliana M Kling Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05447923    
Other Study ID Numbers: 21-009729
NCI-2022-04529 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases